Veterinary Medicines

Revozyn RTU 400 mg/ml Suspension for Injection for Cattle

Authorised
  • Penethamate hydriodide
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Product identification

Medicine name:
Revozyn RTU
Revozyn RTU 400 mg/ml Suspension for Injection for Cattle
Active substance:
  • Penethamate hydriodide
Target species:
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Penethamate hydriodide
    400.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Milk
        4
        day
      • Meat and offal
        10
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01CE90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • United Kingdom (Northern Ireland)
Package description:
  • Multidose 50 ml uncoloured glass (type II, Ph. Eur.) vial, closed with a fluoropolymer coated rubber type I (Ph. Eur.) stopper secured with an aluminium cap.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Eurovet Animal Health B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Eurovet Animal Health B.V.
  • Produlab Pharma B.V.
Responsible authority:
  • The Veterinary Medicines Directorate
Authorisation number:
  • Vm 16849/3000
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0210/001
Concerned member states:
  • Germany
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 19/01/2023
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Dutch (PDF)
Published on: 1/07/2022
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